Acute and Chronic Dental Pain

Keratinized tissue deficiency and gingival recession are common mucogingival problems that may compromise periodontal health, esthetics, and patient comfort. Soft tissue grafting procedures are widely used to increase tissue thickness and volume and to achieve keratinized tissue augmentation. Among autogenous grafting techniques, free gingival grafts (FGG) are considered a predictable and reliable approach for enhancing soft tissue stability and long-term marginal tissue outcomes. Despite their effectiveness, conventional FGG procedures may exhibit postoperative shrinkage and volume reduction due to limited vascularization at the recipient site. To overcome this limitation, a modified free gingival graft (ModFGG) technique has recently been introduced. In this technique, a connective tissue pedicle flap harvested from the apical region of the recession defect is used to cover the exposed root surface prior to placement of the free gingival graft, with the aim of improving graft vascularization and enhancing wound healing. Although previous studies have reported favorable outcomes for ModFGG in terms of root coverage, keratinized tissue gain, and patient satisfaction, available evidence is largely based on two-dimensional clinical measurements. Conventional methods used to assess soft tissue changes, such as periodontal probing, needles, and ultrasonic devices, are either invasive or limited to linear measurements, thereby restricting the evaluation of volumetric tissue alterations. Recent advances in three-dimensional digital analysis techniques allow for reliable, non-invasive, and reproducible assessment of both linear and volumetric soft tissue changes. However, to date, no clinical study has evaluated soft tissue thickness, volumetric changes, and creeping attachment following conventional FGG and ModFGG procedures in mandibular incisors using direct three-dimensional digital analysis. This randomized controlled clinical trial aims to compare the effects of conventional free gingival graft and modified free gingival graft techniques on soft tissue thickness, volumetric changes, and creeping attachment in mandibular incisors using a direct three-dimensional digital evaluation method. Systemically healthy, non-smoking adult patients presenting with localized Cairo Class II gingival recession will be enrolled and randomly allocated to either the FGG (control) group or the ModFGG (test) group. Clinical and digital assessments will be performed at baseline and at 1, 3, and 6 months postoperatively. Soft tissue thickness and volumetric changes will be analyzed by superimposing digital models obtained using an intraoral scanner. Additional clinical parameters, including gingival recession depth, width of keratinized tissue, and probing depth, will also be recorded. The results of this study are expected to provide high-quality evidence regarding the effectiveness of the modified free gingival graft technique in enhancing soft tissue stability and volumetric outcomes in periodontal plastic surgery.

The current randomized clinical trial will be conducted to evaluate the 24-month clinical and radiographic outcomes after revascularization of asymptomatic necrotic immature permanent maxillary incisors using single- or multiple-visit protocol.

Patients diagnosed with stage III or IV periodontitis who exhibit mandibular first or second molars with Class II, Subclass A, or B buccal and/or lingual mandibular furcation defects (horizontal probing depth of ≥ 3 mm ) will be recruited. Patients diagnosed with stage III or IV periodontitis who exhibit maxillary first or second molars with Class II, Subclass A, or B buccal furcation defects (horizontal probing depth of ≥ 3 mm ) if furcation involvement on the palatal side (mesiopalatal and distopalatal) does not exceed Class 1 will be recruited. This study will be a prospective, randomized, single-blinded, controlled clinical trial with a split-mouth design. Patients will be recruited from the clinics of the Riga Stradiņš University Institute of Stomatology of Riga, Latvia. Before the baseline treatment, all patients who meet the inclusion criteria will be given detailed oral hygiene instructions and motivation. Patients' furcation defects in each quadrant will be randomly allocated at a 1:1 ratio to either the application of Oscillating Chitosan Brush with Enamel Matrix Derivatives (test group) or Oscillating Chitosan Brush alone (control group). Non-surgical periodontal treatment of furcation defects on the test side will be performed through the application of Oscillating Chitosan Brush with Enamel Matrix Derivatives and on the control side with Oscillating Chitosan Brush alone. The re-evaluation of periodontal status will be performed 12 weeks following the baseline treatment. Biofilm samples and gingival crevicular fluid (GCF) samples will be taken at the baseline and at 4 weeks.

This will be a single center, randomized, controlled, examiner-blind, 2-arm, stratified, parallel design clinical study in healthy male and female participants, aged 18-70, with self-reported and clinically confirmed DH in a Chinese population in a study design as per the Chinese Ministry of Health (MOH) Guidance. Sufficient participants will be screened so that approximately 100 participants (50 per group) will be stratified according to the maximum baseline Schiff sensitivity score of their two 'Test Teeth' and randomized to ensure approximately 90 evaluable participants (45 per group) complete the study.

DH has a prevalence rate ranging from 1.3% to 92.1%, commonly affecting old ages, and the frequency of DH in patients suffering from periodontal disease is 3-57%. Pakistan has reported prevalence from different cities, with 36.4% from Karachi and 22% from Lahore. The use of laser has opened new dimensions in the treatment of DH. Theories that support laser therapy explain that irradiation blocks the pain in dentinal tubules by melting and recrystallization of dentin or by tertiary dentine production or evaporation of dentinal fluid. Considering the oral soft tissues which contain high amounts of water, Lasotronix SMARTm laser diodes have been carefully designed to show their high transmission. The 635nm wavelength is optimal for activating tolonium chloride dye for photo-activated chemo therapy, eliminating all bacteria and biofilms without any side effects. 200 mW power provides safe cold bio stimulation and photo disinfection within a reasonably short therapy time. Application of Sodium fluoride (NaF) has also been indicated for hypersensitivity pains. Its application in the form of gel occludes the tubule by calcium fluoride precipitation. Agents like potassium nitrate also have promising effects, which increase the concentration of potassium ions in nerve endings and alter the nerve action potential in conducting the sensory stimuli. Recently DH treatment has been conducted with different types of laser with different wavelengths, either alone or in combination with desensitizing agents and varnishes and has revealed effective results. To the author's knowledge, not much research work has been conducted using LASOTRONIX as a treatment modality with CPP-ACP. Therefore, this research aims to determine the effectiveness of Casein phospho peptide paste (CPP-ACP) used alone or combined with a diode laser (LASOTRONIX).

The study will test the investigational product gel against placebo (which contains no active ingredient) to determine if it is safe after wisdom tooth extraction. The main questions the study will answer are: 1. How much of the investigational product is absorbed in the blood? 2. Are there side effects?

Symptomatic irreversible pulpitis is a common endodontic condition characterized by severe inflammatory dental pain. Although root canal treatment (RCT) is effective in removing the inflamed pulp tissue, many patients continue to experience pain during the first 24-48 hours after treatment. Post-operative endodontic pain affects patient comfort, satisfaction, and clinical workflow, making pain control an essential component of evidence-based endodontic care. Traditional pharmacological methods for managing post-operative dental pain include nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids. While these medications are effective, they are also associated with potential gastrointestinal and systemic adverse effects, especially when used repeatedly. As a result, there is growing interest in alternatives that can reduce inflammation and discomfort while minimizing systemic risks. Enzyme-based anti-inflammatory therapies, including combinations of trypsin, bromelain, and rutin, have been shown in medical and dental literature to provide meaningful reductions in pain, edema, and inflammation following surgical procedures. These proteolytic enzymes act by breaking down inflammatory mediators, reducing tissue permeability, and modulating cytokine responses. Trinase, a formulation containing trypsin, bromelain, and rutin, is widely used in postoperative care in other medical fields, yet its role in managing pain following endodontic procedures has not been adequately studied. This randomized, double-blind, placebo-controlled clinical trial is designed to evaluate whether administering Trinase before root canal treatment can reduce the intensity of post-operative pain in patients diagnosed with symptomatic irreversible pulpitis. A total of 182 systemically healthy male patients, aged 18 to 50 years, will be recruited from the Endodontics Department at Fayoum University. The study population is limited to male participants to standardize biological pain variability and hormonal influences on pain perception. Eligible patients must present with restorable mandibular molar teeth and moderate to severe preoperative pain confirmed both clinically and radiographically. Participants will be randomly assigned to one of two equal study arms. The Trinase group will receive a single oral Trinase tablet 30 minutes before treatment. The placebo group will receive a visually identical tablet administered under the same conditions. An assistant not involved in treatment will prepare and code all medication envelopes, ensuring allocation concealment. Both the operator and the participants will be blinded to group assignment. All treatments will be performed in a single visit using standardized endodontic procedures. After local anesthesia, rubber-dam isolation, and access preparation, canal patency will be confirmed using stainless steel hand files. Working length will be determined electronically and confirmed radiographically. Mechanical instrumentation will be performed using Protaper Next rotary instruments according to manufacturer instructions. Irrigation will be performed using 2.5% sodium hypochlorite and EDTA gel lubricant. Upon completion of cleaning and shaping, canals will be dried, obturated using a modified single-cone technique with resin-based sealer, and restored temporarily with intermediate restorative material. All procedures are performed by a single experienced operator to eliminate inter-operator variability. The primary outcome measure is postoperative pain intensity assessed using a 10-cm Visual Analogue Scale (VAS). Patients will record their pain levels at baseline and at 6, 12, 24, and 48 hours after treatment. Pain will be categorized using validated VAS cutoff values. The secondary outcome measure is the total number of analgesic tablets consumed within 48 hours following treatment. Participants will receive a standardized pain diary to document both pain levels and analgesic intake. Statistical analysis will be conducted using non-parametric tests due to expected non-normal distribution of pain scores. Between-group differences will be analyzed using the Mann-Whitney test, and within-group comparisons across time points will be performed using the Friedman test followed by appropriate post-hoc analysis. The significance level will be set at p ≤ 0.05. Sample size was calculated using PS software to detect clinically relevant differences in postoperative pain with an anticipated dropout rate accounted for by enrolling 182 participants. The study protocol has been reviewed and approved by the Fayoum University Supreme Committee for Scientific Research Ethics (FU-SCSRE). Written informed consent will be obtained from each participant. The study involves minimal risk, as Trinase is a commercially available medication with a well-established safety profile and the placebo carries no known risks. The duration of active participation for each subject is approximately 48 hours, corresponding to the postoperative observation period. No additional radiographs or invasive procedures beyond standard clinical care will be performed. This study aims to determine whether Trinase can serve as a simple, safe, and effective adjunct to improve postoperative patient comfort following root canal therapy. The results may help clarify the role of enzyme-based anti-inflammatory medications in endodontic pain management and potentially reduce reliance on traditional analgesics with known adverse effects.

This will be a longitudinal study investigating OHrQoL and treatment patterns amongst new sufferers of self-reported Dentin Hypersensitivity (DH). Over the 12-month study duration, 375 participants suffering from DH will complete questionnaires online once per month.

Study Title: "A prospective, single-arm, non-randomized controlled trial to test the effectiveness, safety and performance of a novel dental obturation material." Protocol Version and Date: Version 1.0 25 May 2023 Device Risk Category: Risk category: Class IIa, Rule 8 - medium risk device (according to EU MDR). Background and Rationale: Endofill (EF) is a low-viscosity, injectable, hydrophilic, light- curable endodontic sealer. It is an easy-to-use, single- material root canal obturation solution that circumvents the disadvantages of existing products, thus improving ease of handling and treatment time while maintaining the clinical outcome of root canal treatments at the level of state-of-the- art treatment methods. Endofill is used after a conventional access cavity preparation, glide path preparation, determination of the working length, cleaning/shaping of a root canal with a suitable device and irrigating/disinfecting the canal with an irrigant solution. Endofill has undergone pre-clinical testing and is a safe product. The benefits and risks of this investigational device shall be elaborated in the protocol. Primary objectives: To test the effectiveness of the Endofill device for root canal obturation up to 12-month follow-up period. To test the performance of the Endofill device evaluated with periapical radiographs immediately on completion of procedure. Secondary objectives: To test the safety and effectiveness, of the Endofill device by evaluating the incidence of re-treatment cases up to a 12-month follow-up period. Primary endpoints Primary effectiveness endpoint: To measure overall healing, through rate of reduction in apical periodontitis, from baseline up to 12 months post-procedure by measuring periapical radiolucency size. Success is measured by the PAI (periapical index) scores which will be recorded at 3m, 6m and 12 months. Success is defined as either a fully healed lesion (i.e., with no periapical radiolucency visible on the radiograph at 12 month follow up) or a healing lesion (i.e., the periapical radiolucency has decreased in size at 12 month follow up compared to pre-procedure radiographic lesion size); with no clinical symptoms such as pain or swelling. Performance endpoint: To measure the successful and complete obturation of root canal measured by examining the periapical radiograph taken immediately after obturation. Secondary endpoints: Safety endpoint: To measure freedom from postoperative pain from completion of procedure up to 1 months of follow-up (FU) period (24 hours, 48 hours, 72 hours, 7 days, and 1 month). Pain is measured by VAS assessment. Secondary effectiveness endpoint: Successful healing of periapical lesion up to 12 months post-procedure. Long-term effectiveness success shall be defined as a continued reduction or complete absence of periapical lesion radiolucency at 12m follow up since procedure with no clinical symptoms (i.e no discomfort in treated tooth and no percussive pain during examination) Device failure shall be defined as root canal re-treatment or extraction requirement due to the treatment itself as the cause of failure, up to 12m post procedure along with persistence of clinical symptoms. The study involves a safety check at 3 months' time point post-procedure. This check will be performed on the first 10 subjects to assess the safety, effectiveness, and performance of the evaluated device. A total of 63 subjects aged 18 years and above shall be included in this study. Study Procedure * Subjects will be selected based on inclusion and exclusion criteria and subjects will be assigned a subject ID code for the study. * Each subject shall receive the endodontic treatment as laid out in this protocol. * Subject dropout is addressed in the statistical analysis plan. * The follow-up period (up to 12 months) shall permit the demonstration of clinical effectiveness, performance and safety over a period of time sufficient to represent a realistic test of the investigational device and allow any risks associated with adverse device effects to be identified and assessed. The planned enrollment period is 6-9 months. The total expected duration of the clinical investigation is 2 - 2.5 years. Statistical Considerations: Full details of the analyses will be discussed in a separate statistical analysis plan (SAP). Briefly, the following endpoints will be analyzed: Primary endpoints are * A reduction in PAI at 12 months compared to baseline. The rate seen will be compared to a target rate of 0.85 using a non-inferiority test at a margin of 0.2. * Successful obturation of the root canal at procedure's completion. The rate will be reported with its 95% Clopper-Pearson CI. The secondary endpoints are * Experiencing different levels of postoperative pain (none, mild, moderate, and severe) at 24 hours, 48 hours, 72 hours, 7 days, 1 month after the procedure. The rates will be reported with their 95% Clopper-Pearson confidence intervals. * Root canal re-treatment in tooth treated with Endofill at 12 months post-procedure. The rate will be reported with its 95% Clopper-Pearson confidence interval. * Duration of the obturation procedure. Summary statistics (mean, median, max, min, IQR, and range) will be reported. Questionnaire about the quality and usability of the device. · Summary statistics of results will be reported. Sample Size In order to be able to establish non-inferiority within a margin of 0.2 of the target rates of 0.85, a two-sided, 95% confidence interval for the healing rate must lie above 0.85 - 0.2 = 0.65. Assuming a pessimistic scenario where the true underlying healing rate of the Endofill device is 0.02 lower than the target rate of 0.85 (i.e., 0.83), data from 56 participants are needed. This yields a power of 80% for the study. Assuming a 10% drop out rate at 12 months, the required sample size is 63.

Study title: "A Comparative Evaluation of Effectiveness in Root Canal Debridement using Inertial Cavitation Device vs Passive Ultrasonic Irrigation and Conventional Preparation: A Randomized Controlled Clinical Trial". Study Design: This is a prospective, 3-arm randomized, non-blinded, single-center pivotal clinical investigation, performed to evaluate the effectiveness and safety of the Endoclean device with 2 comparator arms. Primary objective: To test the effectiveness of the Endoclean device for root canal debridement up to 12-month follow-up. Secondary objective: To test the extended effectiveness and safety of the Endoclean device up to a 24-month follow-up. Inclusion/Exclusion Criteria: 1. Inclusion Criteria •Patients aged between 18-75 years with ASA (American Society of Anesthesiologists) classification 1 and 2. ASA 1: A normal healthy patient. Example: Fit, non-obese BMI (Body mass index) under 30, a non-smoking patient with good exercise tolerance. ASA 2: A patient with mild systemic disease. Example: Patient with no functional limitations and a well-controlled disease (e.g., treated hypertension, obesity with BMI under 35, frequent social drinker, or cigarette smoker). * Patients who agreed to participate and who have signed the informed consent. * Patients presenting with symptomatic and/or asymptomatic apical periodontitis and radiographic evidence of apical periodontitis in anterior or posterior teeth larger than 1.5 mm in diameter. * Mature tooth with closed apices * Tooth that has never been treated with root canal therapy. 2. Exclusion Criteria: * Patients, who have pre-existing health or oral conditions that placed them at risk during the trial. * Patients with generalized untreated periodontal disease. * Patients with a history of analgesic intake within the past 3 days or antibiotics in the last 1 month. * Uncooperative patients * Teeth with immature apices, root resorption, or requiring extensive prosthetic rehabilitation. * Teeth that cannot be made functional nor restored or difficult to access teeth with no importance (wisdom teeth) * Teeth with insufficient periodontal support * Teeth with poor prognosis, for example due to deep root caries, large root resorption or open apex cases * Fractured teeth * Local anatomical factors such as an inaccessible root end * Presence of fractured instrument in the root canal * Pregnant women * Patients unable to understand the study procedure. Number of Participants: Total number of participants = 109 subjects Arm 1: 40 subjects Arm 2: 40 subjects Arm 3: 29 subjects Test device: Endoclean (Lumendo AG): hydraulic cavitation cleaning device Control device 1: Passive ultrasonic irrigation (PUI) Control device 2: Rotary files with standard NaOCl irrigation Study duration: 2-3 years The results of the Endoclean group shall be compared to data gathered from the comparator device groups and results shall be presented in the clinical investigation report.